The following data is part of a premarket notification filed by Kmi Kolster Methods, Inc. with the FDA for Stars2000 Power Cannula.
Device ID | K012236 |
510k Number | K012236 |
Device Name: | STARS2000 POWER CANNULA |
Classification | System, Suction, Lipoplasty |
Applicant | KMI KOLSTER METHODS, INC. 1170 N. GILBERT ST. Anaheim, CA 92801 |
Contact | Alwin H Kolster |
Correspondent | Alwin H Kolster KMI KOLSTER METHODS, INC. 1170 N. GILBERT ST. Anaheim, CA 92801 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-07-17 |
Decision Date | 2001-11-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00851314007069 | K012236 | 000 |